Cellulaze Handpiece, 2 Pack
Catalogue number 100-7014-015, listed by Cynosure, LLC, United States, under Laser, Cellulite Appearance. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
Who Else Makes It
All of them in Beijing.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Winkonlaser Technology Limited | Beijing | Beijing | Contract manufacturer | 14 |
| Beijing Beautemax Technology Limited | Beijing | Beijing | Contract manufacturer | 13 |
Record
| Listed by | Cynosure, LLC, United States |
|---|---|
| FDA product code | OYW |
| Device type | Laser, Cellulite Appearance |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K123407 |
| Record published | 2018-08-24 |
| Record revised | 2023-01-11 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 100-7014-015 | 2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SLT II | El.en. SPA | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K123407 | 2013-03-29 |
| K102541 | 2012-01-26 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.